Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
研究概览
简要总结
The primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD of the ileum, with or without involvement of the caecum or the right colon
- •Colonoscopy showing active lesions defined by a CDEISm score >6
- •Informed consent to participate in this study
- •Prescription of steroid treatments : Budesonide, Prednisone (or Prednisolone) independently from entry in study
- •Patients who respond to budesonide (initial dose 9 mg/d) or prednisone or prednisolone (initial dose 40 mg/d), defined as a 70 points decrease in CDAI between the pre-inclusion and the inclusion visit,
- •Patients colonized with AIEC on initial ileal biopsies.
排除标准
- •Ileal stenosis that cannot be crossed by the endoscope,
- •Infliximab treatment received less than 8 weeks before inclusion in this study,
- •Adalimumab treatment received less than 4 weeks before inclusion in this study,
- •Vedolizumab treatment received less than 8 weeks before inclusion in the study,
- •Hypersensitivity to Ciprofloxacin, to other quinolones, or to any of the excipients (cellulose microcrystalline, crospovidone, maize starch, magnesium stearate, silica colloidal anhydrous,, hypromellose titanium dioxide E171, macrogol 4000,),
- •Tizanidine, Probenecid, Theophylline, Xanthine derivatives, Phenytoin, oral anticoagulants, and Ropinirole treatment,
- •Hypersensitivity to Rifaximin, or to any excipients (sodium starch glycolate type A, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide, disodium edentate, propylene glycol, red iron oxide E172),
- •Previous extensive ileal surgery (≥ 1 meter as measured on the pathology and/or surgical report),
- •Short bowel syndrome,
- •Need for an intestinal resection for fistula, abscess or intestinal obstruction,
- •Renal failure (creatinine clearance<30 mL/min/1.73m2),
- •Liver failure (V factor<50%),
- •Past history of epilepsy,
- •No health insurance,
- •Pregnant or lactating women,
- •Refusal to have a double effective contraception,
- •Patients already included in a biomedical research other than an observational study (e.g: registry, cohort).
研究组 & 干预措施
Experimental arm
oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks
干预措施: Ciprofloxacin (Drug)
Experimental arm
oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks
干预措施: Rifaximin (Drug)
Control arm
a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks
干预措施: Ciprofloxacin Placebo (Drug)
Control arm
a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks
干预措施: Rifaximin Placebo (Drug)
结局指标
主要结局
Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
时间窗: week 12
(assessed within each site quotation), defined by the modified Crohn's Disease Endoscopic Index of Severity (CDEISm)\< 6 and a decrease in CDEISm ≥ 3, as compared to baseline values.
次要结局
- Microbiota composition(weeks 12 and 48)
- No ulceration(week 12)
- Complete endoscopic remission(week 12)
- Biological remission(weeks 4, 8, 12, 24, 36 and 48)
- Mean variation of CDEISm(week 12)
- Clinical remission(12 and 48 weeks)
- lpf positive AIEC bacteria in the stools(weeks 12 and 48)
- Side effects(week 12)